MASH / MASLD Therapeutics Landscape 2025: Pipeline & Market Analysis

Introduction

MASH (Metabolic Dysfunction-Associated Steatohepatitis) has emerged as an area of intense pharmaceutical industry focus due to extremely high unmet medical needs. The year 2025 has been transformative, with major Big Pharma acquisitions significantly reshaping the competitive landscape.

This article provides a comprehensive analysis of the MASH development race in 2025 from the perspectives of acquisitions, partnerships, and approvals.

MASH: Wave of Big Pharma Mega-Acquisitions

Major Acquisition Deals

The MASH space in 2025 witnessed three major Big Pharma acquisitions.

1. GSK → Boston Pharmaceuticals (May 2025)

In May 2025, GSK acquired Boston Pharmaceuticals' lead asset, efimosfermin alfa (formerly BOS-580), for an upfront payment of $1.2 billion, with up to $800 million in potential milestone payments¹².

Key Asset Characteristics:

• Efimosfermin alfa demonstrated significant improvements in liver fibrosis and MASH resolution in Phase 2 trials involving patients with F2/F3 fibrosis³⁴
• GSK plans to develop the drug for a broader range of steatotic liver diseases (SLD), including MASH and alcohol-related liver disease (ALD), targeting commercialization in 2029²⁵

2. Roche → 89bio (September 2025)

In September 2025, Roche acquired 89bio for an upfront payment of $2.4 billion, with an additional $1.1 billion in potential milestone payments (total deal value up to $3.5 billion)⁶⁷.

Key Asset Characteristics:

• Lead candidate pegozafermin is a fibroblast growth factor 21 (FGF21) analog targeting moderate to severe MASH treatment⁶⁸
• Phase 3 trials ENLIGHTEN-Fibrosis (non-cirrhotic F2-F3 patients) and ENLIGHTEN-Cirrhosis (compensated cirrhotic F4 patients) are ongoing⁸⁹
• Topline results from ENLIGHTEN-Fibrosis expected in first half of 2027, and ENLIGHTEN-Cirrhosis in first half of 2028⁹

3. Novo Nordisk → Akero Therapeutics (October 2025)

In October 2025, Novo Nordisk acquired Akero Therapeutics for an upfront payment of $4.7 billion, with up to an additional $500 million contingent upon FDA approval for compensated cirrhosis due to MASH¹⁰¹¹.

Key Asset Characteristics:

• Lead candidate efruxifermin (EFX) is an FGF21 analog that Novo Nordisk believes has "first- and best-in-class" potential for MASH¹⁰¹²
• Under development in Phase 3 SYNCHRONY program for both pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4)¹³¹⁴
• 96-week results from Phase 2b SYMMETRY trial announced in January 2025 showed statistically significant improvement of compensated cirrhosis (F4) due to MASH¹⁵

Approved Therapeutics

Madrigal Pharmaceuticals - Rezdiffra (resmetirom)

• FDA approval obtained in March 2024, conditional marketing authorization from European Commission in August 2025¹⁶¹⁷
• Industry's first approved drug for MASH treatment with F2-F3 fibrosis, leading the market¹⁶
• Launched in Germany in September 2025¹⁷

Novo Nordisk - Wegovy (semaglutide)

• In August 2025, FDA approved for treatment of adult MASH patients with moderate to advanced liver fibrosis (without cirrhosis)¹⁸¹⁹
• In December 2025, Health Canada also granted conditional marketing authorization for non-cirrhotic MASH (F2-F3 fibrosis)²⁰

Companies Seeking Partners

Viking Therapeutics

• Phase 2b VOYAGE trial of lead candidate VK2809 showed favorable 52-week histological data²¹²²
• CEO stated that "a large partner would be very helpful in driving the program through commercialization" and expressed openness to partnership negotiations²³²⁴
• Plans to discuss Phase 3 strategy with FDA²³

Retreating Companies

Gilead Sciences

• In August 2025, discontinued partnership with Novo Nordisk (combination therapy of cilofexor + firsocostat + semaglutide)²⁵
• Also terminated partnership with Korean company Yuhan in October 2024²⁶
• Fibrotic disease pipeline now "entirely empty"²⁵

Industry Map: Visualizing Company Relationships

The following Mermaid diagram visualizes the major acquisitions, approvals, and development status in the MASH space in 2025.

Legend:

• 🔵 Blue: Big Pharma (acquiring companies)
• 🟢 Green: Approved companies
• 🔴 Red: Retreating/discontinued companies
• 🟠 Orange: Companies seeking partners

Analysis: Industry Trend Analysis

1. Big Pharma Acquisition of De-Risked Assets

All three major MASH acquisitions in 2025 (GSK/Boston, Roche/89bio, Novo/Akero) involved "de-risked" assets with positive Phase 2 or later data. This demonstrates Big Pharma's strategy of avoiding early-stage development risks and entering the market after some degree of efficacy has been confirmed.

2. Concentration on FGF21 Analogs

Both pegozafermin (89bio) and efruxifermin (Akero), acquired by Roche and Novo Nordisk respectively, are FGF21 analogs. This concentration indicates that the FGF21 pathway is being valued as a differentiated mechanism for anti-fibrotic and anti-inflammatory effects.

3. Indication Expansion and Combination Strategies

GSK's efimosfermin alfa is pursuing indication expansion beyond MASH to alcohol-related liver disease (ALD). Additionally, the possibility of combination therapy with existing anti-fibrotic drugs is being explored, suggesting that combination strategies will become increasingly important in future development.

Conclusion

The MASH space in 2025 experienced accelerated industry consolidation with multiple Big Pharma mega-acquisitions. GSK, Roche, and Novo Nordisk invested over $8 billion collectively to acquire promising biotech assets and secure market entry.

Moving forward, the Phase 3 results and regulatory approvals of these acquired assets will be closely watched. Particularly, the clinical performance of the FGF21 analogs acquired by Roche and Novo Nordisk from 2027 onwards will significantly shape the future of MASH treatment.

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References

1.GSK Acquires Boston Pharmaceuticals' MASH Asset - MedCity News 2.GSK to Acquire Boston Pharmaceuticals - Contract Pharma 3.Boston Pharmaceuticals Announces Positive Phase 2 Results - Clinical Trial Vanguard 4.Boston Pharmaceuticals Phase 2 Data - Business Wire 5.GSK MASH Pipeline Expansion - Nasdaq 6.Roche to Acquire 89bio - Fierce Biotech 7.Roche 89bio Acquisition Analysis - BioPharma Dive 8.Roche and 89bio Deal Overview - Pharma Phorum 9.89bio ENLIGHTEN Trials Update - MedCity News 10.Novo Nordisk Acquires Akero - MedCity News 11.Novo Nordisk and Akero Deal - BioPharma Dive 12.Novo Nordisk Akero Strategy - BioSpace 13.Akero SYNCHRONY Program Overview 14.Akero Clinical Development Update 15.Akero Phase 2b SYMMETRY Results - BioPharma Dive 16.Madrigal Rezdiffra Approval - BioSpace 17.Madrigal European Approval - BioSpace 18.Wegovy MASH Approval - Pharmaceutical Technology 19.Novo Nordisk Wegovy MASH - PharmTech 20.Wegovy Canada Approval - Newswire 21.Viking Therapeutics VK2809 Data - BioSpace 22.Viking VOYAGE Study Results 23.Viking Therapeutics Partnership Strategy - Fierce Biotech 24.Viking Therapeutics M&A Speculation - BioPharma Dive 25.Gilead MASH Retreat - Fierce Biotech 26.Gilead Yuhan Partnership End - Fierce Biotech